Evidence map›Paper›PMID 26767629›Full record

Trial reportContemporary clinical trials2016

Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL).

Shari S Bassuk, JoAnn E Manson, I-Min Lee, Nancy R Cook, William G Christen, Vadim Y Bubes, David S Gordon, Trisha Copeland, Georgina Friedenberg, Denise M D'Agostino and 4 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 69 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 7 pooled it
10.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01169259 phase3active not recruitingnot on this map

Vitamin D and Omega-3 Trial (VITAL)

TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2026Enrolled25,871ConditionsCancer, Cardiovascular DiseaseArmsvitamin D3, omega-3 fatty acids (fish oil), Vitamin D3 placebo, Fish oil placebo
NCT01758081 naactive not recruitingnot on this map

Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18

TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2026Enrolled25,874ConditionsInfections, Human Cathelicidin Antimicrobial Peptide (hCAP-18)Armsvitamin D3, omega-3 fatty acids (fish oil), Vitamin D3 placebo, fish oil placebo
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 7 syntheses or guidelines pooled it, 98 citations in OpenAlex.

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  10. Vitamin DThe American journal of clinical nutrition · 2025
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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Shari S BassukDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: sbassuk@partners.org.
JoAnn E MansonDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, Massachusetts 02115, United States. Electronic address: jmanson@partners.org.
I-Min LeeDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, Massachusetts 02115, United States. Electronic address: ilee@partners.org.
Nancy R CookDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, Massachusetts 02115, United States. Electronic address: ncook@partners.org.
William G ChristenDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: wchristen@partners.org.
Vadim Y BubesDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: vbubes@partners.org.
David S GordonDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: dgordon@partners.org.
Trisha CopelandDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: pcopeland2@partners.org.
Georgina FriedenbergDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: gfriedenberg@partners.org.
Denise M D'AgostinoDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: ddagostino@partners.org.
Claire Y RidgeDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: cridge@partners.org.
Jean G MacFadyenDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: jmacfadyen@partners.org.
Kate KalanDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States. Electronic address: katekalan@gmail.com.
Julie E BuringDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, Massachusetts 02215, United States; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, Massachusetts 02115, United States. Electronic address: jburing@partners.org.
Brigham and Women's Hospital · US

Funding

VITamin D and omegA-3 triaL (VITAL)U01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2009 to 2014
$23.6M
The VITamin D and OmegA-3 TriaL (VITAL)R01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2015 to 2019
$20.9M
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint PainR01AR059086 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H · 2010 to 2021
$5.4M
VITamin D and OmegA-3 TriaL (VITAL): Interrelationship of Vitamin D and Vitamin K on BoneR01AR059775 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI LEBOFF, MERYL SUSAN · 2012 to 2022
$3.9M
NCI NIH HHS R01 CA138962NCI NIH HHS U01 CA138962NIAMS NIH HHS R01 AR059086NIAMS NIH HHS R01 AR059775
6 · The paper itself

Abstract

Evidence for a role of supplemental vitamin D and marine omega-3 fatty acids in preventing cancer and cardiovascular disease (CVD) remains inconclusive and insufficient to inform nutritional recommendations for primary prevention. The VITamin D and Omega-A 3 TriaL (VITAL) is an ongoing nationwide, randomized, double-blind, placebo-controlled clinical trial designed to fill this knowledge gap. The study population consists of 25,874 U.S. adults without cancer or CVD at baseline, who were selected only on age (men aged ≥50 and women aged ≥55), with an oversampling of African Americans (n=5,107). In a 2 × 2 factorial design, participants were randomized to one of four supplement groups: [1] active vitamin D3 (cholecalciferol; 2000 IU/d) and active marine omega-3 fatty acids (Omacor® fish oil, eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA], 1g/d); [2] active vitamin D and omega-3 placebo; [3] vitamin D placebo and active marine omega-3 fatty acids; or [4] vitamin D placebo and omega-3 placebo. The mean length of the randomized treatment period will be 5 years. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The similar distribution of known potential confounders across treatment groups strongly suggests that unmeasured or unknown potential confounders are also equally distributed. VITAL is expected to provide important information on the benefit-risk balance of vitamin D and omega-3 fatty acid supplementation when taken for the primary prevention of cancer and CVD.

Indexed as

Dietary SupplementsAgedAged, 80 and overCardiovascular DiseasesCholecalciferolClinical ProtocolsDocosahexaenoic AcidsDouble-Blind MethodDrug CombinationsEicosapentaenoic AcidFemaleHumansMaleMiddle AgedNeoplasmsPatient SelectionCholecalciferolDocosahexaenoic AcidsDrug CombinationsEicosapentaenoic AcidOmacorVitaminsCancerCardiovascular diseaseOmega-3 fatty acidsPrimary preventionRandomized clinical trialVitamin D

Identifiers

PMID26767629
PMCPMC4818165
OpenAlexW2292962337

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.